MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 9F X 95CM; CATHETER, PERCUTANEOUS

Model Number 90074

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Event Description

It was reported during a right internal carotid artery (ica) thrombus case when the balloon (subject device) was delivered to the treatment site and inflated, contast agent was found leaking from it.The ballon was removed and a hole was found on the device.It was repalced and the procedure was completed successfully with no clinical consequences to the patient.

Manufacturer Narrative

Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The device was returned with no packaging.During visual inspection, the subject balloon was noted to be damaged.During functional testing, an attempt was made to inflate the balloon however a leak was noted.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that they delivered a balloon to occlude the blood flow and when dilating the balloon, it was found that the balloon leaked.The contrast agent went out of balloon.After the procedure the operator checked the balloon and found it damaged.Additional information provided stated the device was prepared for use as per the directions for use, was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The subject balloon was inflated with a 1 ml injection, the correct inflation medium was used to inflate the balloon as per the directions for use (dfu), and the device was inflated over nominal pressure, nominal, there was no leakage noted during preparation.An assignable cause of user error will be assigned to the reported event of the balloon has hole/perforation during use, balloon leaked during use and to the analysed defect of the balloon has hole/perforation during use and the balloon leaked during use, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.

Event Description

It was reported during a right internal carotid artery (ica) thrombus case when the balloon (subject device) was delivered to the treatment site and inflated, contrast agent was found leaking from it.The balloon was removed and a hole was found on the device.It was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: MERCI BGC 9F X 95CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15266125
• MDR Text Key: 305252692
• Report Number: 3012931345-2022-00163
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: 00815742000740
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: 90074
• Device Catalogue Number: 90074
• Device Lot Number: 0000106568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1